EU regulatory
policies, mainly
established by
guidelines issued
by the EMA and
revised periodically,
can now draw
upon more than
a decade of
experience
manufacturer could be held liable in failure to warn
or design defect claims is limited. 9
From a medical liability perspective, if a patient
switched to a biosimilar experiences adverse events
or loss of efficacy, the medical liability chain will
be different from that in the case of generics.
Moreover, the case of treatment-naïve patients
will be different from that of non-naïve patients.
In the case of naïve patients, physicians choose
from a range of medicinal products with the same
unknown/the same risk (it is not possible to know
patients’ responses to each therapeutic option until
they have taken the drug). In contrast, in the case
of non-naïve patients, when physicians switch to a
biosimilar, they are switching from an option where
the individual response is known to an option where
it is unknown. 9
16 | 2019 | hospitalpharmacyeurope.com
The EU legislative framework
In the EU, biotechnological medicinal products
fall under the provisions of Regulation EC No.
726/2004, while the legal basis for biosimilars lies
in the Directive 2001/83/EC (as amended). The
authorisation process for biosimilars of polypeptide-
based products is the same as that of protein-based
products. The regulatory policy for biosimilars is
outlined mainly in general and product class-specific
guidelines issued by the EMA, addressing quality,
non-clinical and clinical issues. 10 Table 1 summarises
some of the guidelines.
The MA application is supported by a dossier
containing the required data in a standard format
(known as the common technical document (CTD)).
The CTD is composed of five modules:
• Module 1: specific administrative data;